QA Complaint Handling Specialist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Gelderland Netherlands.
• Supporting and guiding audits from the beginning to the end
• To overview processes and applications conducted by your team which includes supplier containment, CAPA’s , Document control, and risk management
• Implementation, monitoring and maintenance of FDA Quality standards, ISO and Medical Device Regulations
• Establishment and maintenance of relationships with departments and external authorities
• Following up on FMEA in collaboration with the Quality manager and other process managers
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
• Key contact person for QMS related topics and questions
• Minimal 5 years of experience within the Medical Devices industry
• Minimal 2 years of experience in a Quality Assurance role
• Experienced in complaint handling, risk management and procedures
• Excellent knowledge of ISO 13485
• Team player, yet strong individual
• Excellent analytical skills
• Fluency in English and Dutch
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Ewout de Jong
The Company
This organisation is market leader in the development and innovation of cleanroom packaging. They are specialised in thermoformed packaging solutions for the pharmaceutical and medical device industry. They are operating worldwide and they are currently looking for expansion.Role Description
In your role as a Quality Assurance specialist, you will provide support to the QA team regarding the Quality Assurance System and all related activities. You will help to improve the QMS and you will have a major role when it comes down to various procedures such as the development of strategies for compliancy, participation in both internal and external audits, and changes for ISO qualifications. You will be contacted whenever there are any particular issues with the ISO standards, the Quality Management System, and related documentation or legislation.Responsibilities
• Updating and maintaining the QMS and related procedures• Supporting and guiding audits from the beginning to the end
• To overview processes and applications conducted by your team which includes supplier containment, CAPA’s , Document control, and risk management
• Implementation, monitoring and maintenance of FDA Quality standards, ISO and Medical Device Regulations
• Establishment and maintenance of relationships with departments and external authorities
• Following up on FMEA in collaboration with the Quality manager and other process managers
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
• Key contact person for QMS related topics and questions
Requirements
• Bachelor in Life Sciences• Minimal 5 years of experience within the Medical Devices industry
• Minimal 2 years of experience in a Quality Assurance role
• Experienced in complaint handling, risk management and procedures
• Excellent knowledge of ISO 13485
• Team player, yet strong individual
• Excellent analytical skills
• Fluency in English and Dutch
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Ewout de Jong
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